Medical Device Standards Management Center of the National Medical Products Administration and in collaboration with the Zhejiang Medical Device Inspection and Research Institute, the Draft Guiding Principles for Classification and Definition of Medical Devices for Myopia Control and Amblyopia Treatment were formulated and made available for public input yesterday, .

objective:

The guiding principles aim to standardize the management attributes and categories of medical devices used for myopia control and amblyopia treatment. This standardization aligns with the regulations set forth in the Medical Device Supervision and Management Regulations, Medical Device Classification Rules, and Medical Device Classification Catalog.

Scope:

The principles apply to medical devices for myopia control and amblyopia treatment as defined by traditional Chinese medicine medical devices in the Regulations on the Supervision and Administration of Medical Devices. These devices are utilized for myopia control, training, and amblyopia treatment through visual observation or irradiation. Exclusions encompass ophthalmic measurement diagnostic equipment, ophthalmic laser surgical treatment equipment, intraocular lighting equipment, and contact lens products.

Definition of Management Attributes:

Management attributes are determined based on the expected use and mechanism of action of the products. Products failing to meet the traditional Chinese medicine medical device definition are not classified as medical devices, such as those used for general eye care and relief of visual fatigue.

Definition of Categories for Medical Device Management:

The management category of medical devices for myopia control and amblyopia treatment should be comprehensively determined based on their light source characteristics, structural characteristics, expected use, and usage form.

The management category of medical devices for myopia control and amblyopia treatment should be comprehensively determined based on their light source characteristics, structural characteristics, expected use, and usage form.

When the product is used for myopia control or training, it should be judged according to the following principles:

a. If the product uses laser as the light source to directly irradiate the fundus of the eye (such as the macular area of the retina) for myopia control, it is managed as a Class III medical device with the classification code 16-05.

b. If the product uses other types of non-laser light (such as red light generated by LED) to directly illuminate the fundus of the eye (such as the macular area of the retina) for myopia control, it is managed as a Class III medical device with the classification code 16-05.

c. If the product uses other types of non-laser light (such as LED light) to relax or tense the ciliary muscles of the eyes (such as guiding the eyes to see far or near through the movement of visual aids) for myopia training, it is managed as a Class II medical device with the classification code 19-01.

When the product is used for the treatment of amblyopia, it should be judged based on the following principles:

a. If the product uses laser as the light source to directly irradiate the fundus of the eye (such as the macular area of the retina) for the treatment of amblyopia, it is managed as a Class III medical device with the classification code 16-05.

b. If the product uses other types of non-laser light (such as red light generated by LED) to directly illuminate the fundus of the eye (such as the macular area of the retina) for the treatment of amblyopia, it is managed as a Class III medical device with the classification code 16-05.

c. If the product uses other types of non-laser light (such as LED light) to trigger visual stimulation through flash, grating, light brush, post image, de-suppression, stereo vision, fusion vision, as well as visual tracking, contrast training, sensitivity training, and fine vision training for the treatment of amblyopia, it is managed as a Class II medical device with the classification code 16-03.

If the product is used for myopia training or amblyopia treatment training and is independent software that does not use artificial intelligence algorithms, it will be managed as a Class II medical device with the classification code 21-06.

Medical devices for myopia control and amblyopia treatment cannot be classified under the physical therapy devices category in the 09 Classification Catalogue of Medical Devices.

Note: Products that use laser or other types of non-laser light (such as red light generated by LED) to directly irradiate the fundus should fully consider factors such as cumulative damage to the patient's retina during clinical use and be used with caution.

Requirements

From the date of publication of these guiding principles, registration applications for medical devices for myopia control and amblyopia treatment shall be accepted in accordance with the above principles.

Registration and renewal applications that have already been accepted for medical devices should be immediately suspended from review and approval.

For devices that have been approved and registered as medical devices but need to change their management attributes or categories, the current registration certificate will remain valid during its validity period. The registrants involved should actively work on converting the registration in accordance with the relevant requirements of management attributes and categories. This conversion must be completed before July 1, 2024. Starting from July 1, 2024, any products that have not obtained the corresponding medical device registration certificate shall not be produced or sold.